Rheumatoid Arthritis
Conditions
Brief summary
The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only from subjects providing informed consent.
Interventions
OTHERAs per clinical practice
As per clinical practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eighteen years of age or older 2. Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria: 1. Morning stiffness in and around the joints lasting at least 1 hour; 2. Arthritis of 3 or more joint areas; 3. Arthritis of hand joints; 4. Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body; 5. Rheumatoid nodules; 6. Serum Rheumatoid Factor (RF) 7. Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks. 3. Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology 4. Patients naive to anti-TNF drugs 5. Outpatients
Exclusion criteria
Patients involved in controlled or interventional trials in the 12 previous months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short-Form Health Survey (SF-36) at Month 12 | Month 12 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 9 | Month 9 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 12 | Month 12 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). |
| Visual Analogue Scale for Pain (VAS-pain) at Month 3 | Month 3 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 | Month 3 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (\<) 2.6. |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6 | Month 6 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \<2.6. |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9 | Month 9 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \<2.6. |
| Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12 | Month 12 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \< 2.6. |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 3 | Month 3 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | Month 6 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 9 | Month 9 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 | Month 12 | DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 3 | Month 3 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 6 | Month 6 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 9 | Month 9 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. |
| Patient Global Assessment (PtGA) of Disease Activity Score at Month 12 | Month 12 | PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad. |
| Physician Global Assessment (PGA) of Disease Activity at Month 3 | Month 3 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. |
| Physician Global Assessment (PGA) of Disease Activity at Month 6 | Month 6 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. |
| Physician Global Assessment (PGA) of Disease Activity at Month 9 | Month 9 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. |
| Physician Global Assessment (PGA) of Disease Activity at Month 12 | Month 12 | PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible. |
| Visual Analogue Scale for Pain (VAS-pain) at Month 6 | Month 6 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. |
| Visual Analogue Scale for Pain (VAS-pain) at Month 9 | Month 9 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. |
| Visual Analogue Scale for Pain (VAS-pain) at Month 12 | Month 12 | 10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain. |
| C-reactive Protein (CRP) at Month 3 | Month 3 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. |
| C-reactive Protein (CRP) at Month 6 | Month 6 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. |
| C-reactive Protein (CRP) at Month 9 | Month 9 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. |
| C-reactive Protein (CRP) at Month 12 | Month 12 | CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation. |
| Erythrocyte Sedimentation Rate (ESR) at Month 3 | Month 3 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. |
| Erythrocyte Sedimentation Rate (ESR) at Month 6 | Month 6 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. |
| Erythrocyte Sedimentation Rate (ESR) at Month 9 | Month 9 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. |
| Erythrocyte Sedimentation Rate (ESR) at Month 12 | Month 12 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation. |
| Number of Participants With Rheumatoid Factor (RF) at Month 3 | Month 3 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. |
| Number of Participants With Rheumatoid Factor (RF) at Month 6 | Month 6 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. |
| Number of Participants With Rheumatoid Factor (RF) at Month 9 | Month 9 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. |
| Number of Participants With Rheumatoid Factor (RF) at Month 12 | Month 12 | RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 | Month 3 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 | Month 6 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 | Month 9 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. |
| Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 | Month 12 | Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive. |
| Number of Participants With Anti-nuclear Antibodies at Month 3 | Month 3 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. |
| Number of Participants With Anti-nuclear Antibodies at Month 6 | Month 6 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. |
| Number of Participants With Anti-nuclear Antibodies at Month 9 | Month 9 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. |
| Number of Participants With Anti-nuclear Antibodies at Month 12 | Month 12 | Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive. |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 | Month 3 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 | Month 6 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 | Month 9 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. |
| Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 | Month 12 | Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive. |
| Duration of Morning Stiffness at Month 3 | Month 3 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Duration of Morning Stiffness at Month 6 | Month 6 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Duration of Morning Stiffness at Month 9 | Month 9 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Duration of Morning Stiffness at Month 12 | Month 12 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 3 | Month 3 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). |
| Stanford Health Assessment Questionnaire (HAQ) Score at Month 6 | Month 6 | HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indirect Costs | Baseline, Months 3, 6, 9 and 12 | Indirect costs represent the loss of resources as a consequence of work disability or unemployment. |
| Direct Costs | Baseline, Months 3, 6, 9 and 12 | Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator's discretion were observed for a period of 12 months. | 299 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Changed hospital center | 2 |
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Anti-tumor Necrosis Factor (Anti-TNF) Agents |
|---|---|
| 36-Item Short-Form Health Survey (SF-36) Indice sintetico salute fisica del (ISF) | 38.8 Units on a Scale STANDARD_DEVIATION 10.6 |
| 36-Item Short-Form Health Survey (SF-36) Indice sintetico salute mentale del (ISM) | 48.0 Units on a Scale STANDARD_DEVIATION 13.2 |
| Age, Customized 18 to 34 years | 29 Participants |
| Age, Customized 35 to 49 years | 72 Participants |
| Age, Customized 50 to 64 years | 133 Participants |
| Age, Customized Greater than or equal to (>=) 65 years | 65 Participants |
| Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies NA | 78 Participants |
| Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies Negative | 97 Participants |
| Anti-cyclic Citrullinated Protein (Anti-CCP) antibodies Positive | 124 Participants |
| Anti-deoxyribonucleic Acid (Anti-DNA) antibodies NA | 120 Participants |
| Anti-deoxyribonucleic Acid (Anti-DNA) antibodies Negative | 173 Participants |
| Anti-deoxyribonucleic Acid (Anti-DNA) antibodies Positive | 6 Participants |
| Anti-nuclear antibodies NA | 91 Participants |
| Anti-nuclear antibodies Negative | 170 Participants |
| Anti-nuclear antibodies Positive | 38 Participants |
| C-reactive Protein (CRP) | 3.3 milligram/deciliter (mg/dL) STANDARD_DEVIATION 6.3 |
| Disease Activity Score Based on 28-joints count (DAS28) | 5.4 Units on a scale STANDARD_DEVIATION 1.2 |
| Disease duration | 5.0 Years |
| Duration of morning stiffness | 61.8 minutes STANDARD_DEVIATION 48 |
| Erythrocyte Sedimentation Rate (ESR) | 32.9 millimeter/hour (mm/hr) STANDARD_DEVIATION 22 |
| Number of swollen joints (SJC) | 7.3 Swollen joints STANDARD_DEVIATION 5.3 |
| Number of tender joints | 11.0 Tender joints STANDARD_DEVIATION 7.1 |
| Patient Global Assessment (PtGA) | 6.6 centimeter (cm) STANDARD_DEVIATION 2.1 |
| Percentage of participants given Disease Modifying Anti-Rheumatoid Drugs (DMARD) | 98.3 Percentage of participants |
| Percentage of participants with Disease Activity Score Based on 28-joints count (DAS28) remission | 1.7 Percentage of participants |
| Physician Global Assessment (PGA) | 6.1 cm STANDARD_DEVIATION 1.7 |
| Rheumatoid Factor (RF) Negative | 118 Participants |
| Rheumatoid Factor (RF) Not available (NA) | 18 Participants |
| Rheumatoid Factor (RF) Positive | 163 Participants |
| Sex: Female, Male Female | 230 Participants |
| Sex: Female, Male Male | 69 Participants |
| Stanford Health Assessment Questionnaire (HAQ) | 1.4 Units on a scale STANDARD_DEVIATION 0.7 |
| Visual Analogue Scale for Pain (VAS-pain) | 6.7 cm STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 272 |
| serious Total, serious adverse events | 0 / 272 |
Outcome results
Primary
36-Item Short-Form Health Survey (SF-36) at Month 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | 36-Item Short-Form Health Survey (SF-36) at Month 12 | ISF | 52.2 Units on a Scale | Standard Deviation 14.7 |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | 36-Item Short-Form Health Survey (SF-36) at Month 12 | ISM | 55.5 Units on a Scale | Standard Deviation 11.8 |
Primary
C-reactive Protein (CRP) at Month 12
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | C-reactive Protein (CRP) at Month 12 | 1.5 mg/dL | Standard Deviation 2.6 |
Primary
C-reactive Protein (CRP) at Month 3
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | C-reactive Protein (CRP) at Month 3 | 1.4 mg/dL | Standard Deviation 2.5 |
Primary
C-reactive Protein (CRP) at Month 6
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | C-reactive Protein (CRP) at Month 6 | 1.3 mg/dL | Standard Deviation 2.5 |
Primary
C-reactive Protein (CRP) at Month 9
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | C-reactive Protein (CRP) at Month 9 | 1.1 mg/dL | Standard Deviation 1.6 |
Primary
Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 | 3.6 Units on a Scale | Standard Deviation 1.5 |
Primary
Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Disease Activity Score Based on 28-joints Count (DAS28) at Month 3 | 4.2 Units on a Scale | Standard Deviation 1.3 |
Primary
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | 3.7 Units on a Scale | Standard Deviation 1.3 |
Primary
Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Disease Activity Score Based on 28-joints Count (DAS28) at Month 9 | 3.4 Units on a Scale | Standard Deviation 1.2 |
Primary
Duration of Morning Stiffness at Month 12
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Duration of Morning Stiffness at Month 12 | 17.8 minutes | Standard Deviation 23.8 |
Primary
Duration of Morning Stiffness at Month 3
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Duration of Morning Stiffness at Month 3 | 26.4 minutes | Standard Deviation 26.3 |
Primary
Duration of Morning Stiffness at Month 6
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Duration of Morning Stiffness at Month 6 | 19.6 minutes | Standard Deviation 32.7 |
Primary
Duration of Morning Stiffness at Month 9
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Duration of Morning Stiffness at Month 9 | 13.2 minutes | Standard Deviation 17.5 |
Primary
Erythrocyte Sedimentation Rate (ESR) at Month 12
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Erythrocyte Sedimentation Rate (ESR) at Month 12 | 21.9 mm/hr | Standard Deviation 18.9 |
Primary
Erythrocyte Sedimentation Rate (ESR) at Month 3
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Erythrocyte Sedimentation Rate (ESR) at Month 3 | 23.9 mm/hr | Standard Deviation 18.8 |
Primary
Erythrocyte Sedimentation Rate (ESR) at Month 6
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Erythrocyte Sedimentation Rate (ESR) at Month 6 | 20.8 mm/hr | Standard Deviation 16.2 |
Primary
Erythrocyte Sedimentation Rate (ESR) at Month 9
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Erythrocyte Sedimentation Rate (ESR) at Month 9 | 18.4 mm/hr | Standard Deviation 13.5 |
Primary
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 | Positive | 52 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 | Negative | 45 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 | NA | 175 Participants |
Primary
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 | Negative | 50 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 | NA | 174 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 | Positive | 43 Participants |
Primary
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 | Positive | 44 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 | Negative | 44 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 | NA | 147 Participants |
Primary
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 | Positive | 32 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 | Negative | 39 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 | NA | 154 Participants |
Primary
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 | Positive | 3 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 | Negative | 88 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 | NA | 181 Participants |
Primary
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 | Negative | 79 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 | NA | 187 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 | Positive | 1 Participants |
Primary
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 | Positive | 1 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 | Negative | 80 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 | NA | 154 Participants |
Primary
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 | Positive | 4 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 | Negative | 60 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 | NA | 161 Participants |
Primary
Number of Participants With Anti-nuclear Antibodies at Month 12
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 12 | Positive | 14 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 12 | Negative | 85 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 12 | NA | 173 Participants |
Primary
Number of Participants With Anti-nuclear Antibodies at Month 3
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 3 | Positive | 8 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 3 | Negative | 78 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 3 | NA | 181 Participants |
Primary
Number of Participants With Anti-nuclear Antibodies at Month 6
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 6 | Positive | 14 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 6 | Negative | 79 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 6 | NA | 142 Participants |
Primary
Number of Participants With Anti-nuclear Antibodies at Month 9
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 9 | Positive | 9 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 9 | Negative | 57 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Anti-nuclear Antibodies at Month 9 | NA | 159 Participants |
Primary
Number of Participants With Rheumatoid Factor (RF) at Month 12
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 12 | Positive | 88 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 12 | Negative | 67 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 12 | NA | 117 Participants |
Primary
Number of Participants With Rheumatoid Factor (RF) at Month 3
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 3 | Positive | 80 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 3 | Negative | 88 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 3 | NA | 98 Participants |
Primary
Number of Participants With Rheumatoid Factor (RF) at Month 6
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 6 | Positive | 77 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 6 | Negative | 74 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 6 | NA | 83 Participants |
Primary
Number of Participants With Rheumatoid Factor (RF) at Month 9
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 9 | Positive | 63 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 9 | Negative | 57 Participants |
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Number of Participants With Rheumatoid Factor (RF) at Month 9 | NA | 106 Participants |
Primary
Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Patient Global Assessment (PtGA) of Disease Activity Score at Month 12 | 3.3 cm | Standard Deviation 2.6 |
Primary
Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Patient Global Assessment (PtGA) of Disease Activity Score at Month 3 | 4.1 cm | Standard Deviation 2.3 |
Primary
Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Patient Global Assessment (PtGA) of Disease Activity Score at Month 6 | 3.4 cm | Standard Deviation 2.4 |
Primary
Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Patient Global Assessment (PtGA) of Disease Activity Score at Month 9 | 2.8 cm | Standard Deviation 2.3 |
Primary
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \< 2.6.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12 | 22.6 Percentage of participants |
Primary
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (\<) 2.6.
Time frame: Month 3
Population: Intent-to-Treat (ITT) population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 | 13.4 Percentage of participants |
Primary
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \<2.6.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6 | 21.6 Percentage of participants |
Primary
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 \<2.6.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9 | 27.2 Percentage of participants |
Primary
Physician Global Assessment (PGA) of Disease Activity at Month 12
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Physician Global Assessment (PGA) of Disease Activity at Month 12 | 2.8 cm | Standard Deviation 2.4 |
Primary
Physician Global Assessment (PGA) of Disease Activity at Month 3
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Physician Global Assessment (PGA) of Disease Activity at Month 3 | 3.7 cm | Standard Deviation 2.1 |
Primary
Physician Global Assessment (PGA) of Disease Activity at Month 6
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Physician Global Assessment (PGA) of Disease Activity at Month 6 | 2.9 cm | Standard Deviation 2.1 |
Primary
Physician Global Assessment (PGA) of Disease Activity at Month 9
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Physician Global Assessment (PGA) of Disease Activity at Month 9 | 2.3 cm | Standard Deviation 2.1 |
Primary
Stanford Health Assessment Questionnaire (HAQ) Score at Month 12
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Stanford Health Assessment Questionnaire (HAQ) Score at Month 12 | 0.8 Units on a Scale | Standard Deviation 0.7 |
Primary
Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Stanford Health Assessment Questionnaire (HAQ) Score at Month 3 | 1.0 Units on a Scale | Standard Deviation 0.7 |
Primary
Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Stanford Health Assessment Questionnaire (HAQ) Score at Month 6 | 0.7 Units on a Scale | Standard Deviation 0.7 |
Primary
Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Stanford Health Assessment Questionnaire (HAQ) Score at Month 9 | 0.7 Units on a Scale | Standard Deviation 0.7 |
Primary
Visual Analogue Scale for Pain (VAS-pain) at Month 12
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time frame: Month 12
Population: ITT population included all participants who received at least 1 dose of the study medication. Missing values were imputed using LOCF.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Visual Analogue Scale for Pain (VAS-pain) at Month 12 | 3.3 cm | Standard Deviation 2.7 |
Primary
Visual Analogue Scale for Pain (VAS-pain) at Month 3
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time frame: Month 3
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Visual Analogue Scale for Pain (VAS-pain) at Month 3 | 4.1 cm | Standard Deviation 2.4 |
Primary
Visual Analogue Scale for Pain (VAS-pain) at Month 6
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time frame: Month 6
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Visual Analogue Scale for Pain (VAS-pain) at Month 6 | 3.3 cm | Standard Deviation 2.3 |
Primary
Visual Analogue Scale for Pain (VAS-pain) at Month 9
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
Time frame: Month 9
Population: ITT population included all participants who received at least 1 dose of the study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anti-tumor Necrosis Factor (Anti-TNF) Agents | Visual Analogue Scale for Pain (VAS-pain) at Month 9 | 2.9 cm | Standard Deviation 2.4 |
Secondary
Direct Costs
Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.
Time frame: Baseline, Months 3, 6, 9 and 12
Population: There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.
Secondary
Indirect Costs
Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
Time frame: Baseline, Months 3, 6, 9 and 12
Population: There was not a direct data collection on costs. Zero participants were analyzed for this outcome measure.